Drug product
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5554-3.
D-0295-2021
Product summary
- Event
- Event 87373
- Status
- Terminated
- Classification
- Class II
- Quantity
- 786,900 patches
- Official record key
drug-enforcement:D-0295-2021
Official wording
Reason: Defective Delivery System: Out of specification for mechanical peel.
Code information: Lots #: 87580, Exp 4/2021, 87819, Exp 4/2021, 88244, Exp 6/2021, 88245, Exp 6/2021, 88532, Exp 06/2021 & 88533, Exp 7/2021.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification